US7288225B2 - Irradiation of ispaghula - Google Patents

Irradiation of ispaghula Download PDF

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Publication number
US7288225B2
US7288225B2 US10/258,894 US25889403A US7288225B2 US 7288225 B2 US7288225 B2 US 7288225B2 US 25889403 A US25889403 A US 25889403A US 7288225 B2 US7288225 B2 US 7288225B2
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Prior art keywords
ispaghula
kgy
radiation
dose
husks
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US10/258,894
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US20030156972A1 (en
Inventor
Michael Edward Havler
Peter William Dettmar
Glyn Owen Phillips
Saphwan Al-Assaf
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Reckitt Benckiser Healthcare UK Ltd
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Reckitt Benckiser Healthcare UK Ltd
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Assigned to RECKITT BENCKISER HEALTHCARE (UK) LIMITED reassignment RECKITT BENCKISER HEALTHCARE (UK) LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PHILLIPS, GLYN OWEN, AL-ASSAF, SAPHWAN, DETTMAR, PETER WILLIAM, HAVLER, MICHAEL EDWARD
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/68—Plantaginaceae (Plantain Family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives

Definitions

  • the present invention relates to a method for the production of medicinal compositions, in particular to a method for the production of ispaghula-containing compositions wherein the ispaghula is sanitised and optimised for inclusion in ingestible compositions.
  • Ispaghula is obtained from the plant species Plantago ovata . Ispaghula is sometimes referred to as psyllium.
  • Ingestible ispaghula-containing compositions for the relief of gastric and digestive dysfunctions are known.
  • the efficacy of ispaghula for the relief of such dysfunctions, including constipation, is well recognised and commercial formulations are readily available.
  • examples of such compositions include particulate ispaghula intended to be stirred in measured amount into a volume of liquid, usually water or a soft drink. After stirring, the drinking composition is intended to be quickly imbibed due to the propensity of the ispaghula to absorb water readily and swell to form a viscous gel-like mass. It is the property of water absorption which is the desired characteristic of ispaghula in compositions for gastric and digestive dysfunctions. Once the ispaghula has absorbed water to produce the gel-like mass, the mass is relatively insoluble and fibrous, and is transported through the gut quickly with minimal digestion, helping to alleviate constipation and the like.
  • the ispaghula in such compositions to comprise the seed husks or hulls of the ispaghula plant.
  • the seeds, including the husks are usually harvested from the plant, then dried, then subjected to a mechanical treatment, to separate the seed kernels from the husks.
  • the broken husks then generally make up over 50% by weight of the ispaghula portion of the ingestible composition, with the remaining ispaghula portion predominantly being the seed kernels themselves.
  • the seed kernels are removed, because they are less palatable than the husks.
  • the ispaghula can be processed, following removal of the seeds if wished, by grinding, flaking or other known operations but may be used without any further processing.
  • the ispaghula used in such compositions is a natural product obtained from plants, purity is of great concern.
  • the ispaghula compositions are to be imbibed or otherwise consumed, it is desired that the ispaghula is sanitised to kill off any foreign biological matter such as insects and microorganisms entrapped within the ispaghula material.
  • ispaghula when used in the relief of gastric and digestive dysfunctions is its ability to absorb water in the gut and form a viscous, fibrous mass which is quickly transported through the gut without absorption from it.
  • a method for the production of an ingestible composition comprising ispaghula, the method comprising the step of irradiating the ispaghula, such that the dose of radiation absorbed by the ispaghula is at least 4 kGy and no more than 13 kGy.
  • the dose of radiation absorbed by the ispaghula is suitably sufficient to effect sanitisation.
  • Suitably is at least 5 kGy, preferably at least 6 kGy, and more preferably at least 7 kGy.
  • it does not exceed 12 kGy, and most preferably does not exceed 10 kGy.
  • 1 kGy (Gray) equals 1 Joule per kilogram.
  • the ispaghula in its untreated form (that is, without irradiation) the ispaghula has a fairly compact tertiary structure of long polysaccharide chains, able to absorb a certain amount of water in a reasonably short period of time in the gut. The absorption of water in the gut swells the ispaghula to form a fairly viscous gel-like mass which is not readily absorbed by the gut and travels quickly through it.
  • the dose of radiation absorbed by the ispaghula is less than 7 kGy.
  • the dose of radiation again breaks down certain of the long chain polysaccharides present in ispaghula into smaller-chain polysaccharides.
  • the polysaccharides do not break down to the extent required to open up the tertiary structure of the ispaghula but form internal traps which allow specific interaction with water. Ingestion of the treated ispaghula allows colonic bacteria to continue the degradation required to further open up the tertiary structure and allow increased water absorption to swell the ispaghula to the optimum viscosity for quick passage through the gut.
  • the radiation used during the method may be corpuscular (for example ⁇ -particles or ⁇ -particles) or, preferably, electromagnetic (for example x-rays or, more preferably, ⁇ -rays).
  • the radiation used during the method is ⁇ -radiation.
  • the frequency of the ⁇ -radiation is typically in the range 10 20 -10 24 Hz.
  • the source of the preferred ⁇ -radiation may suitably be a Cobalt-60 source or, preferably a Caesium-137 source.
  • the ispaghula used in the method of the invention may comprise whole ispaghula seeds, but preferably at least part of the ispaghula comprises separated ispaghula seed husks. More preferably the ispaghula comprises at least 50% wt separated ispaghula husks, most preferably at least 95% wt separated ispaghula husks. Suitably the remainder of the ispaghula comprises other seed parts and/or other ispaghula plant materials. In preferred compositions the seeds kernels themselves have been substantially removed to leave the husks.
  • the ispaghula may undergo mechanical processing, for example granulation or flaking, and this may occur prior to irradiation or after irradiation.
  • the ispaghula is mixed with one or more co-ingredients to form the desired ingestible composition.
  • the ispaghula is irradiated prior to mixing with the co-ingredients but it can be envisaged that in certain embodiments of the invention the co-ingredients are mixed with the ispaghula before irradiation, the amount of radiation being absorbed by the ispaghula component of the formulation being kept at no more than 13 kGy by suitable adjustment of the dose rate.
  • Suitable co-ingredients may, for example, be selected from one or more of bicarbonates, for example sodium bicarbonate, ingestible acids, for example citric acid, flavourings and colourings.
  • the invention also extends to a composition comprising ispaghula when provided by the irradiation method described herein.
  • the composition may be formed into a solid tablet or capsule for direct ingestion by a user.
  • the composition is provided in a particulate solid form, for example as powder or flakes intended to be mixed with water, immediately prior to ingestion by a user.
  • FIGS. 1 and 2 are plots showing the relevant properties of ispaghula treated in accordance with the invention.
  • Ispaghula husk material (1 kg) obtained from Plantago ovata , and broken down to enable the seed kernels to be removed, was taken at random from a 25 kg sack.
  • Samples of the ispaghula material (4 g) were placed in glass stoppered tubes and introduced to a radiation source ( 137 Cs, ⁇ -source) for varying time periods to achieve a range of treatment dose levels.
  • the dose rate of the source was determined using a Fricke dosimeter found to be 0.65 kGy/min. From this accurately determined rate, the dose to each sample could be calculated respectively as 2 kGy, 4 kGy, 6 kGy, 8 kGy, 15 kGy and 22 kGy,
  • G′ Storage modulus
  • FIG. 1 presents storage modulus (G′), loss modulus (G′′) and dynamic viscosity (n′), at a frequency of 1.29 Hz plotted as a function of irradiation dose for the 4 wt % ispaghula husk in 0.15 M sodium chloride.
  • Example 1 show that when the ispaghula husks are subjected to doses of absorbed radiation up to about 7 kGy the storage modulus loss modulus and dynamic viscosity are largely unaffected. It is believed to be the case that the long-chain polysaccharides in the ispaghula husks are beginning to be broken down to smaller-chain polysaccharides, but not enough to affect the compact, relatively structured tertiary structure of the ispaghula. Thus as no further ordering of the structure is occurring there is little opening up of the structure or increase in viscosity over non-irradiated samples.
  • the storage and loss moduli and the dynamic viscosity can be seen to increase, compared with non-irradiated samples.
  • the increase is a very substantial one, given that the y-axis uses a logarithmic scale. This change is believed to be due to the long-chain polysaccharides in the ispaghula husks being broken down to smaller-chain polysaccharides and internal traps sufficient to open up the compact tertiary structure of the ispaghula. Once the structure is opened up it becomes more ordered during interaction with water and the viscosity increases.
  • FIG. 2 The results are shown in FIG. 2 . It will be seen that the plots are similar to those shown in FIG. 1 , except that the peak improvement is seen with a radiation dose of 6 kGy, rather than 8 kGy. This may be a function of the batch of ispaghula used, of the orientation of the chains in the ispaghula, of the larger scale employed, of the ⁇ -source used or of the tolerances involved in the test, particularly as regards the measurement of irradiation in the larger scale method. In any event however, the experiments of Examples 1 and 2 are consistent in showing substantial specific beneficial effects centred around the 6-8 kGy mark.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Botany (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Radiation-Therapy Devices (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Physical Or Chemical Processes And Apparatus (AREA)
US10/258,894 2000-05-10 2001-05-10 Irradiation of ispaghula Expired - Fee Related US7288225B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0011169.0 2000-05-10
GBGB0011169.0A GB0011169D0 (en) 2000-05-10 2000-05-10 Improvements in or relating to medicinal compositions
PCT/GB2001/002040 WO2001085190A1 (en) 2000-05-10 2001-05-10 Irradiation of ispaghula

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US20030156972A1 US20030156972A1 (en) 2003-08-21
US7288225B2 true US7288225B2 (en) 2007-10-30

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US (1) US7288225B2 (de)
EP (1) EP1286681B1 (de)
CN (1) CN1221286C (de)
AT (1) ATE273016T1 (de)
AU (2) AU2001260425B2 (de)
BR (1) BR0110572A (de)
CA (1) CA2407743A1 (de)
DE (1) DE60104842T2 (de)
ES (1) ES2221901T3 (de)
GB (2) GB0011169D0 (de)
WO (1) WO2001085190A1 (de)
ZA (1) ZA200209053B (de)

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Publication number Priority date Publication date Assignee Title
JP5415867B2 (ja) * 2008-09-30 2014-02-12 株式会社パナケイア製薬 便秘治療薬およびその製造方法

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1184514A (en) 1967-04-21 1970-03-18 Japan Atomic Energy Res Inst Fermentation Processes.
US3992147A (en) 1974-10-21 1976-11-16 G. D. Searle & Co. Process for sterilizing psyllium seed husk using aqueous isopropanol
EP0105195A2 (de) 1982-09-01 1984-04-11 G.D. Searle & Co. Verfahren zum Desinfizieren von hydrophilen Pflanzenschleimen von Plantago durch Extrusion
GB2145320A (en) 1983-08-25 1985-03-27 John Edward Morris Processing and products of oil palm fruit
EP0308003A2 (de) 1987-09-16 1989-03-22 The Procter & Gamble Company Verfahren und Geräte zur Desinfektion von Materialien mit überhitztem Dampf
WO1996000094A1 (en) 1994-06-24 1996-01-04 Coloplast A/S An adhesive agent and use of such agent
GB2310126A (en) 1996-02-16 1997-08-20 Reckitt & Colmann Prod Ltd Sanitising ispaghula
US5688775A (en) * 1991-10-15 1997-11-18 Fmc Corporation β-1,3-glucan polysaccharides, compositions, and their preparation and uses
US6063061A (en) * 1996-08-27 2000-05-16 Fusion Medical Technologies, Inc. Fragmented polymeric compositions and methods for their use
US20030027883A1 (en) * 2001-03-13 2003-02-06 Phillips Glyn Owen Biopolymers obtained by solid state irradiation in an unsaturated gaseous atmosphere

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1184514A (en) 1967-04-21 1970-03-18 Japan Atomic Energy Res Inst Fermentation Processes.
US3992147A (en) 1974-10-21 1976-11-16 G. D. Searle & Co. Process for sterilizing psyllium seed husk using aqueous isopropanol
EP0105195A2 (de) 1982-09-01 1984-04-11 G.D. Searle & Co. Verfahren zum Desinfizieren von hydrophilen Pflanzenschleimen von Plantago durch Extrusion
GB2145320A (en) 1983-08-25 1985-03-27 John Edward Morris Processing and products of oil palm fruit
EP0308003A2 (de) 1987-09-16 1989-03-22 The Procter & Gamble Company Verfahren und Geräte zur Desinfektion von Materialien mit überhitztem Dampf
US5688775A (en) * 1991-10-15 1997-11-18 Fmc Corporation β-1,3-glucan polysaccharides, compositions, and their preparation and uses
WO1996000094A1 (en) 1994-06-24 1996-01-04 Coloplast A/S An adhesive agent and use of such agent
GB2310126A (en) 1996-02-16 1997-08-20 Reckitt & Colmann Prod Ltd Sanitising ispaghula
US6063061A (en) * 1996-08-27 2000-05-16 Fusion Medical Technologies, Inc. Fragmented polymeric compositions and methods for their use
US20030027883A1 (en) * 2001-03-13 2003-02-06 Phillips Glyn Owen Biopolymers obtained by solid state irradiation in an unsaturated gaseous atmosphere

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Dem' Yanenko, V. H. et al. "Radiation Technology of the Preparation of Phyto Drugs," Farmatsevtychnyi Zhurnal (Kiev), (1989) No. 1, pp. 45-47. *
Gopal, N. G. S. et al. "Effect of Heat Ethylene Oxide and Gamma Radiation on Psyllium Husk," Indian Journal of Pharmaceutical Sciences, (1987) vol. 49, No. 2, pp. 75-76. *
Lokhande, H.T.; Varadarajan, P.V. "A New Guargum-based Superabsorbent Polymer Synthesised Using Gamma Radiation as a Soil Additive," Bioresource Technology, v. 42(2), 1992, p. 119-22. *

Also Published As

Publication number Publication date
WO2001085190A1 (en) 2001-11-15
CN1221286C (zh) 2005-10-05
GB2364913A (en) 2002-02-13
ZA200209053B (en) 2003-11-07
US20030156972A1 (en) 2003-08-21
ES2221901T3 (es) 2005-01-16
EP1286681A1 (de) 2003-03-05
GB2364913B (en) 2002-05-08
EP1286681B1 (de) 2004-08-11
CN1427724A (zh) 2003-07-02
DE60104842D1 (de) 2004-09-16
GB0111422D0 (en) 2001-07-04
HK1057007A1 (en) 2004-03-12
CA2407743A1 (en) 2001-11-15
ATE273016T1 (de) 2004-08-15
BR0110572A (pt) 2003-04-01
AU6042501A (en) 2001-11-20
GB0011169D0 (en) 2000-06-28
DE60104842T2 (de) 2005-09-01
AU2001260425B2 (en) 2005-11-17

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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HAVLER, MICHAEL EDWARD;DETTMAR, PETER WILLIAM;PHILLIPS, GLYN OWEN;AND OTHERS;REEL/FRAME:014094/0268;SIGNING DATES FROM 20030116 TO 20030223

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